22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode RF System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GM HELIX ACQUA IMPLANT,TI,5.0X16
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
FDA 510(k)
FDA Unclassified
·Unknown
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
FDA 510(k)
FDA Class 2
·Dental
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018
GM DRIVE ACQUA IMPLANT 3.5X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018
GM HELIX ACQUA IMPLANT 3.75X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM HELIX IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018
GM HELIX ACQUA IMPLANT 3.5X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
FREESTYLE LIBRE 3
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LTD·Product code QBJ·May 21, 2026
GM DRIVE IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
BIOMET CABLE SYSTEM
FDA Adverse Event
Malfunction
·EBI, LLC.·Product code JDQ·June 11, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 17, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·June 5, 2020
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 12, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019